Thoratec Corp. - May 18, 2012
Issue Date
May 18, 2012
Region
Pacific
Category
Device
$117.00
Address 1
6035 Stoneridge Dr
City
Pleasanton
State
CA
Zip/Postal Code
94588
Country
United States
Inspection Range
Apr 25, 2012 - May 18, 2012
Pages
3
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): Linda Linh T. Nguyen